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Brief Title: Exemestane in Hormone Receptor Positive High Grade Ovarian Cancer
Official Title: EXemestane in Progesterone and/or Estrogen Receptor Positive Epithelial Ovarian Cancer: A Randomized Phase III Trial, EXPERT
Study ID: NCT04460807
Brief Summary: In this Italian, multicenter, randomized, double-blind, placebo controlled, phase III study the efficacy of exemestane will be evaluated in addition to the standard front line treatment in patients with hormone-receptor-positive high grade serous or endometrioid Epithelian Ovarian Cancer (EOC). The patients enrolled in the EXPERT trial will receive exemestane or placebo in addition to standard treatment. Patients and investigators will be blinded to study treatment. The hypothesis underlying the proposed clinical trial is that exemestane added to standard first line therapy will significantly prolong median progression free survival (PFS).
Detailed Description: Estrogen and Progesterone play a role in promoting EOC growth, metastasis, and progression. Recent data show that ER and PgR expression is frequent in high grade EOC and has prognostic significance. A large meta-analysis showed a clinical benefit with any endocrine treatment, and in particular for aromatase inhibitors (AIs), with a greatere benefit for ER+ and/or PgR+ patients and platinum sensitive tumors. Moreover, the analysis of a few randomized clinical trials (RCTs) showed a reduced mortality with endocrine therapy in EOC, suggesting that ER and PgR have a predictive role and that inhibition of their activation could therefore be a treatment option for EOC. Exemestane is a well-tolerated and effective AI in endocrine sensitive breast cancer which inhibits the production of Estrogens by the adipose tissue in postmenopausal women. In this Italian, multicentre, randomized, double-blind, placebo controlled, phase III study will be assessed the efficacy of exemestane versus placebo in addition to the standard front line treatment in patients with high grade serous or endometrioid EOC, IHC positive (≥ 10%) ER or PgR disease, stage IIB - IV according to the FIGO classification. The primary objective of the study is to test the superiority of exemestane over placebo in addition to the standard front line treatment in terms of PFS. Secondary Objectives are: 1. to test whether the percent expression of ER and PgR is predictive of the effect of exemestane on PFS; 2. to test whether the addition of exemestane to the standard front line treatment can prolong Overall Survival (OS); 3. to evaluate objective response rate Overall Response Rate (ORR) of experimental treatment compared with the standard one; 4. to assess whether the effect of exemestane is affected by the proliferative index Ki67; 5. to evaluate the effect of exemestane on Quality of Life (QoL); 6. to evaluate the compliance to the study treatment; 7. to evaluate the safety profile of the experimental treatment compared with the standard one. Study design: a total of 468 subjects (234 per Arm) will be randomized in a 1:1 ratio to receive either standard chemotherapy treatment plus exemestane (Experimental arm) or standard chemotherapy plus placebo (Control arm). Exemestane/placebo will be self-administered as a single oral tablet of 25 mg/day until disease progression, unacceptable toxicity or physician/patient decision to withdraw, whichever comes first. Radiological disease assessments and CA125 will be performed at baseline and every 4 months from randomization, until end of study or disease progression whichever comes first. Safety assessments will be performed at each cycle during standard chemotherapy treatment, then at each study visit, up to 30 days after the last Experimental Treatment administration.Quality of Life will be assessed by a menopause-specific questionnaire, administered to patients at baseline (T0), at 12 months (T1) and at disease progression (T2). For patients who have signed the specific informed consent, tissues and blood samples will be collected.
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: FEMALE
Healthy Volunteers: No
AO SS Antonio e Biagio e Cesare Arrigo, Alessandria, AL, Italy
Ospedale Oncologico IRCCS Bari, Bari, BA, Italy
Ospedale degli Infermi, Biella, BI, Italy
AULSS 1 Dolomiti - Ospedale "Santa Maria del Prato", Feltre, BL, Italy
Azienda Ospedaliero Universitaria Policlinico S.Orsola-Malpighi, Bologna, BO, Italy
ASST degli Spedali Civili di Brescia, Brescia, BS, Italy
Fondazione Poliambulanza, Brescia, BS, Italy
Ospedale di Manerbio, Manerbio, BS, Italy
AOU Cagliari, Policlinico Universitario, Cagliari, CA, Italy
Ospedale Policlinico "SS. Annunziata", Chieti, CH, Italy
Azienda Sanitaria Locale CN2, Alba, CN, Italy
Azienda Ospedaliera S.Croce e Carle, Cuneo, CN, Italy
Ospedale di Mondovì CN1, Mondovì, CN, Italy
Ospedale Sant Anna di Como, Como, CO, Italy
ARNAS Garibaldi, Catania, CT, Italy
Azienda Ospedaliera per l'emergenza Cannizzaro, Catania, CT, Italy
Istituto Scientifico Romagnolo per lo Studio e la Cura dei Tumori (IRST) IRCCS, Meldola, FC, Italy
Ospedale Casa Sollievo della Sofferenza, San Giovanni Rotondo, FG, Italy
ASL 3 Ospedale Villa Scassi, Genova, GE, Italy
IRCCS AOU San Martino - IST, Genova, GE, Italy
ASST Lecco - Ospedale "A. Manzoni", Lecco, LC, Italy
Ospedale "Vito Fazzi", Lecce, LE, Italy
UOS Oncologia Ginecologica, Ospedale S. Gerardo, Monza, MB, Italy
Presidio Ospedaliero Unico Av3, Macerata, MC, Italy
Istituto Europeo di Oncologia (IEO), Milano, MI, Italy
AOU Policlinico di Modena, Modena, MO, Italy
A.R.N.A.S. Ospedali Civico Di Cristina Benfratelli, Palermo, PA, Italy
Ospedale "Guglielmo da Saliceto", Piacenza, PC, Italy
Azienda Ospedaliero-Universitaria Pisana, Pisa, PI, Italy
CRO Centro di Riferimento Oncologico, Aviano, PN, Italy
Fondazione IRCCS Policlinico San Matteo, Pavia, PV, Italy
Azienda Ospedaliera Regionale San Carlo, Potenza, PZ, Italy
Ospedale "degli Infermi", Faenza, RA, Italy
Ospedale "Umberto I", Lugo, RA, Italy
Ospedale Santa Maria delle Croci, Ravenna, RA, Italy
Azienda Ospedaliera Arcispedale Santa Maria Nuova, Reggio Emilia, RE, Italy
Policlinico Umberto I, Università di Roma "La Sapienza", Roma, RM, Italy
Policlinico Universitario Fondazione Agostino Gemelli, Roma, RM, Italy
ASST Valtellina e Alto Lario, Sondrio, SO, Italy
Azienda Ospedaliero Universitaria di Sassari, Sassari, SS, Italy
Fondazione del Piemonte per l'Oncologia - IRCCS, Candiolo, TO, Italy
AO Ordine Mauriziano, Torino, TO, Italy
Azienda Ospedaliero-Universitaria Città della Salute e della Scienza - Ospedale Ostetrico Ginecologico Sant'Anna, Torino, TO, Italy
Presidio Ospedaliero S. Andrea, Vercelli, VC, Italy
Medical Oncology Division, Ente Ospedaliero Ospedali Galliera, Genova, , Italy
Istituto Nazionale Tumori - IRCCS "Fondazione G.Pascale", Napoli, , Italy
Azienda Ospedaliero-Universitaria Maggiore della Carità, Novara, , Italy
Name: Andrea DeCensi
Affiliation: E.O. Ospedali Galliera Genova
Role: PRINCIPAL_INVESTIGATOR